FDA.reportPublic FDA data

Coated VICRYL

Primary DI
10705031472150
Brand
Coated VICRYL
Company
ETHICON, LLC
Model
VCP776D
Catalog number
VCP776D
Device description
Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, absorbable, synthetic, polyglycolic acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032420000
K132580000
K181652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032420000MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREETHICON, Inc.2003-10-22GAM
K132580000COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREETHICON, Inc.2014-02-28GAM
K181652000Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureETHICON, Inc.2018-09-28GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031472154PackageGS112In Commercial Distribution
10705031472150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503147215430705031472154
1070503147215010705031472150

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester and containing an agent to locally inhibit bacterial growth, intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
079402290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031471863VICRYLVCP1828HVCP1828H2026-08-19
10705031472167Coated VICRYLJ4751GJ4751G2026-08-19
10705031472211VICRYLJ1744GJ1744G2026-08-19
10705031472228VICRYLJ1735GJ1735G2026-08-19
10705031005730PERMA-HAND482T482T2015-09-01
10705031010468ETHILON7707G7707G2015-09-01
10705031010482ETHILON7711G7711G2015-09-01
10705031022461ETHILON9030G9030G2015-09-01
10705031022515ETHILON9033G9033G2015-09-01
10705031027077PROLENED7007D70072015-09-01
10705031030893PROLENED8679D86792015-09-01
10705031031968PROLENED9068D90682015-09-01
10705031032972PROLENED9399D93992015-09-01
10705031033061PROLENED9425D94252015-09-01
10705031026926ETHILOND6906D69062015-09-01
10705031244955STRATAFIXSXPP1A431SXPP1A4312018-01-26
10705031244986STRATAFIXSXPP1A415SXPP1A4152018-01-26
10705031245013STRATAFIXSXPP1A429SXPP1A4292018-01-26
10705031245020STRATAFIXSXPP1A428SXPP1A4282018-01-26
10705031245037STRATAFIXSXPP1A427SXPP1A4272018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224453MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
10705031464285STRATAFIXETHICON, LLCGAM2023-03-24
10705031464292STRATAFIXETHICON, LLCGAM2023-03-24
10705031464308STRATAFIXETHICON, LLCGAM2023-03-24
10705031464315STRATAFIXETHICON, LLCGAM2023-03-24
10705031464322STRATAFIXETHICON, LLCGAM2023-03-24
10705031464339STRATAFIXETHICON, LLCGAM2023-03-24
10705031464346STRATAFIXETHICON, LLCGAM2023-03-24
10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24
10705031464452STRATAFIXETHICON, LLCGAM2023-03-24